MAUDE Adverse Event Report: BIOMERIEUX SA VITEK® MASS SPECTROMETER; VITEK® MS

Model Number 410710

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/08/2017

Event Type  malfunction  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

A customer in (b)(6) contacted biomérieux to report a misidentification of corynebacterium as abotrophia defectiva in association with the vitek® ms system.The strain was isolated from a positive blood culture from a child (positive in 48 hours).The strain presented as gram + bacillus, coryneform, positive catalase growing on blood agar.These characteristics are in contradiction with the proposed vitek® ms identification of abotrophia defectiva.The customer did not perform any other alternate method of testing to confirm a correct organism identification.The customer stated there was no adverse impact to patient treatment or state of health due to the discrepant result.Evaluation of the vitek® ms mzml data files indicated that instrument fine-tuning should be performed.The local field service engineer (fse) visited the customer site and performed the fine-tuning process; upon retest of the patient sample, a result of noid (no identification) was obtained.A result of noid is a valid result and indicates to the user that further identification testing is necessary; in addition, the result indicates the fine-tuning process had an impact on the results analysis.The customer did not comply with biomérieux request to retest the sample via alternate method.Culture submittal has been requested by biomérieux for internal investigation.Biomérieux investigation will be initiated.

Manufacturer Narrative

An internal biomérieux investigation was performed with results as follows: two (2) strains were submitted by the customer; however, only one was expected.Analysis of mzml files was performed.System was not operational during test performed on 08feb2017.The organism was subcultured on colombia blood agar (cba) culture media and tested on 16s.Sequencing 16s gave an identification to brevibacterium ravenspurgense (99.57%) for strain a and brevibacterium ravenspurgense (99.59%) for strain b.The orientation tests (performed by the quality control lab) confirmed this identification.The expected species (brevibacterium ravenspurgense) is not included in any vitek® ms knowledge base (kb).Vitek® ms system identification is based on a species pattern classification.The system limitation is due to the use of a predictive modeling based on a supervised learning.Typically, such a model includes an algorithm that learns certain properties (peaks presence) from a training spectra dataset in order to make those predictions.When the microorganism tested is not part of the training dataset, no specific species pattern will be available in the database for comparison.Consequently, the system can give: no identification (most probable answer) when the spectrum acquired doesn't match with any species pattern.An incorrect single choice identification to the nearest pattern species (often same genus than expected) when the spectrum acquired presents high level of similarity with a specific species pattern present in the database.A low discrimination identification (often the same genus than expected) when the spectrum acquired presents high level of similarity with multiple specific species patterns present in the database.This limitation is not mentioned in the vitek® ms knowledge base (kb) user manual: kb v2.0 clinical ex-us: manual ref 161150-137-d.However, on 25jan2017, the kb user manual ref.161150-556-b for vitek® ms clinical use v3.0 was published and mentions the following limitations: "testing of species not found in the database may result in an unidentified result or a misidentification.Interpretation of results and use of the vitek® ms system require a competent technician who should judiciously make use of experience, specimen information, and other pertinent procedures before reporting the identification of test organisms.Additional information known to the user, such as gram stain reaction, colonial and cellular morphology, and growth aerobically or in co2 should be considered when accepting vitek® ms results".Fsca 3305 has also been published on february 2017 in order to inform the customers about this system limitation.The suspected root cause of the issue is vitek® ms system limitation and non-optimal fine tuning.

• Brand Name: VITEK® MASS SPECTROMETER
• Type of Device: VITEK® MS
• Manufacturer (Section D): BIOMERIEUX SA; chemin de l orme; marcy l etoile, rhone 69280 ; FR 69280
• Manufacturer (Section G): BIOMERIEUX SA; chemin de l orme; marcy l etoile, rhone 69280 ; FR 69280
• Manufacturer Contact: ellen weltmer ; 595 anglum road; st. louis, MO 63042 ; 3147317301
• MDR Report Key: 6387345
• MDR Text Key: 69389974
• Report Number: 3002769706-2017-00048
• Device Sequence Number: 1
• Product Code: PEX
• UDI-Device Identifier: 03573026359119
• UDI-Public: 03573026359119
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K124067
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 10/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 410710
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/09/2017
• Initial Date FDA Received: 03/08/2017
• Supplement Dates Manufacturer Received: 09/15/2017
• Supplement Dates FDA Received: 10/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1